21 May 2020 - - The US Food and Drug Administration has approved the investigational new drug application submitted by Switzerland-based protein products Octapharma's Octapharma USA business for a phase three clinical trial on the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression, the company said.

The primary objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose Octagam 10% therapy will slow or stop respiratory deterioration in patients with severe coronavirus disease.

The secondary objectives of the study are to measure the effects of a high-dose of Octagam 10% on slowing or stopping the clinical progression of COVID-19 by improving pulmonary function, quality of life, and correlated impact on metabolic factors.

The study will begin immediately at approximately 10 US research sites with the goal of enrolling about 54 adult patients diagnosed with COVID-19 with a resting SpO2 of ≤93%, requiring oxygen supplementation.

SpO2, also known as oxygen saturation, is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen.

Patients in the trial will be randomized to receive either Octagam 10% or a placebo, and will be monitored for approximately 33 days.

Those receiving Octagam 10% will be administered a total dose of 2 g/kg as an intravenous infusion of 0.5 g/kg over a two-hour period daily for four consecutive days. Octapharma hopes to report study results by 3Q20.

The coronavirus has been a known pathogen in animals since the early 1970s that resulted in gastrointestinal symptoms.

Bats have been identified as the main carrier and cats have been identified as the primary means of transmission to other animals.

In late 2019, the coronavirus evolved to infect the human respiratory system (SARS-CoV-2) as seen in the outbreak in Wuhan, China.